BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Solventum Orthodontics Corporation

    Reg #: 3032027578 · FEI: 3032027578 · Expires 2026
    View on FDA
    Products
    36
    Proprietary Names
    42
    Establishment Types
    6
    Classifications
    36

    Research this establishment in seconds

    The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Registration Details

    Registration Name
    Solventum Orthodontics Corporation
    Registration Number
    3032027578
    FEI Number
    3032027578
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2724 South Peck Rd.
    City
    Monrovia
    State
    CA
    ZIP
    91016
    Country
    US

    Regulatory Submissions

    510(k) Number
    K020394

    Owner / Operator

    Firm Name
    Solventum US LLC
    Operator Number
    10091183
    Address
    12930 IH 10 West
    City
    San Antonio
    State
    TX
    Postal Code
    78249
    Country
    US
    Correspondent
    JEFFERY J SCHORR

    Products

    Device Name Product Code
    Aligner, Bracket, Orthodontic ECQ
    Tube, Orthodontic DZD
    Gauge, Depth, Instrument, Dental EIL
    Band, Elastic, Orthodontic ECI
    Material, Impression Tray, Resin EBH
    Tube Impression And Matrix KCQ
    Forceps, Dressing, Dental EFL
    Headgear, Extraoral, Orthodontic DZB
    Bracket, Metal, Orthodontic EJF
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Bracket, Plastic, Orthodontic DYW
    Band, Material, Orthodontic DYO
    Agent, Tooth Bonding, Resin KLE
    Mirror, Mouth EAX
    Alloy, Other Noble Metal EJS
    Aligner, Sequential NXC
    Bracket, Ceramic, Orthodontic NJM
    Bur, Dental EJL
    Instruments, Dental Hand DZN
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Syringe, Restorative And Impression Material EID
    Setter, Band, Orthodontic ECR
    Instrument, Ligature Tucking, Orthodontic ECP
    Spring, Orthodontic ECO
    Wax, Dental, Intraoral EGD
    Material, Tooth Shade, Resin EBF
    Wire, Orthodontic DZC
    Pusher, Band, Orthodontic ECS
    Plier, Orthodontic JEX
    Applicator, Resin KXR
    Clamp, Wire, Orthodontic ECN
    Tray, Impression, Preformed EHY
    Scaler, Periodontic EMN
    Band, Preformed, Orthodontic ECM
    Activator, Ultraviolet, For Polymerization EBZ
    Retainer, Screw Expansion, Orthodontic DYJ

    Proprietary Names

    Boone Bracket Positioning Gauge Bracket Positioning Gauges Orthodontic Elastics Action Line Thread and Tubing Lingual Rotation Wedge AlastiK Ligatures, Chain, Separators, Modules Incognito Indirect Bonding Tray Unitek Traction Release Headgear Friction-Stop Adjustage Facebow Level Anchorage Facebow NWO Snap-way Series 5 Facebow NWO Headgear Unitek Multi-Cure Glass Ionomer Orthodontic Band Cement Mouth Mirror SILVER SOLDER Clarity Burs OPTICLUDE ORTHOPTIC EYE PATCH OPTICLUDE 3M¿ Nexcare¿ Opticlude Orthoptic Eye Patch 3M(TM) Nexcare(TM) Gentle Removal Eye Patch Molar Band Seater Orthodontic Wax Incognito Hi-T Transbond Supreme LV Light Cure Adhesive Transbond Supreme LV Adhesive, Transbond Supreme Adhesive, Transbond Supreme Low Viscosity Adh Lightweight Band Seater and Pusher Prestige Gurin Auxiliaries Unitek Crimpable Hooks and Posts Sickle-Style Cement Remover Victory Series (TM) Bands Unitek (TM) Bands Transbond XT Transbond LR 3M Unitek Orthodontic Expansion Screws

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Device in the United States for Export Only